标的α射线治疗的全球市场:市场规模，药物核准，专利技术，临床试验相关洞察(2028年)

放射免疫疗法代表了现代医学的重大进步，它使用放射性同位素专门针对并消除患病组织。传统上，β和γ发射核素已广泛用于各种治疗应用，包括治疗癌症、甲状腺疾病和某些神经系统疾病。 β粒子因其中等穿透能力而被认为在对抗细胞恶性肿瘤方面发挥着重要作用。另一方面，伽马射线可以更深入地穿透组织，因此经常用于成像和治疗干预。然而，儘管它们有效，但这些辐射具有某些缺点，例如对邻近健康组织的潜在损害以及难以获得精确的局部效果。

α发射核素的引入彻底改变了放射性药物领域。这些粒子的特征是高线性能量转移 (LET) 和非常有限的穿透深度，在消除癌细胞的同时不伤害周围的健康组织，提供卓越的精确度。这一特性使得α发射粒子在针对微转移性疾病或孤立的恶性细胞时特别有利，并且代表了相对于传统β射线和伽马射线疗法的显着改进。

标靶α疗法（TAT）领域的一项重要成就是Xofigo（二氯化镭223）的核准。这种α发射放射性药物已被批准用于治疗具有症状性骨转移但无内臟转移的去势抵抗性前列腺癌（CRPC）患者。此次批准基于关键的 3 期 ALSYMPCA 试验，该试验证明了在患者生存和疼痛缓解方面的显着优势，为晚期前列腺癌的疼痛管理建立了新标准。 Xofigo 目前已在 50 多个国家/地区获得批准，以支援全球临床和商业成功。

儘管 Xofigo 是目前唯一获准的 α 发射疗法，但 α 标靶治疗领域正在快速发展，特别是对于实体肿瘤。研究人员正在积极研究各种α发射物质，以提高治疗效果并扩大治疗应用。其中，Lead-212 已成为一个特别有前途的选择，在许多临床前和临床研究中显示出潜力。此外，犹他大学最近的研究正在评估标靶α疗法在治疗阿兹海默症等神经退化性疾病的有效性。这证明了α发射设备在解决各种复杂的医疗问题方面的适应性和广泛潜力。

对 TAT 的兴趣不仅限于现有公司；新进业者正在引入新机制并增加 α 发射疗法的种类，从而改变竞争环境。创新的兴起正在推动合作伙伴关係、投资和合作研究计划，为进一步的临床和商业进步创造动力。随着市场的发展，阿尔法发射设备在精准医疗中的重要性预计将不断增长，这使得人们对多种疾病的更有效、侵入性更小的治疗方案感到乐观。凭藉着标靶α疗法的潜力，放射性药物的未来似乎有望解决现代医学中一些最迫切的挑战。

本报告提供全球标的α射线治疗市场相关调查，提供市场概要，以及药物趋势，临床试验趋势，各地区趋势，及加入此市场的主要企业竞争情形等资讯。

目录

第1章 标的α射线治疗的简介

第2章 标的α射线治疗- 结构与作用机制

• 结构
• 作用机制

第3章 标的α射线治疗的应用，癌症

• 造血恶性肿瘤
• 固态肿瘤

第4章 全球标的α射线治疗市场洞察

• 目前市场情势
• 未来的成长的道

第5章 标的α射线治疗市场洞察，各地区

• 美国
• 欧洲
• 中国
• 日本
• 澳洲

第6章 标的α射线治疗的临床试验相关企业，国家，适应症，各期的考察

• 研究
• 前临床
• 第一阶段
• 第一/二阶段
• 第二阶段
• 第二/三阶段
• 第三阶段

第7章 企业，国家，各适应症看了的市售的标的α射线治疗的临床性洞察

第8章 Xofigo- 最初已批准标的α射线治疗

第9章 标的α射线治疗- 企业独自的技术平台

第10章 全球标的α射线治疗市场动态

• 促进因素和机会
• 课题与阻碍因素

第11章 竞争情形

• Actinium Pharma
• AdvanCell
• Bayer
• Fusion Pharma
• Johnson & Johnson
• Modulation Therapeutics
• Orano Med
• Perspective Therapeutics
• RayzeBio
• Telix Pharmaceuticals

Global Targeted Alpha Therapy Market Size, Drugs Approval, Proprietary Technologies & Clinical Trials Insight 2028 Report Highlights:

• Global Targeted Alpha Therapy Market Insight By Region
• Approved Targeted Alpha Therapy Dosage & Pricing Insight
• Number Of Targeted Alpha Therapy In Clinical Trials: > 20 Drugs
• Targeted Alpha Therapy Clinical Trials Insight By Company, Country, Indication & Phase
• Marketed Targeted Alpha Therapy Clinical Insight By Company, Country & Indication
• Targeted Alpha Therapy Proprietary Technology Platform Insights By Company

Radioimmunotherapy marks a notable progression in modern medicine, utilizing radioactive isotopes to specifically target and eliminate diseased tissues. Traditionally, beta and gamma emitters have been extensively employed across various therapeutic applications, such as in the treatment of cancer, thyroid disorders, and certain neurological ailments. Beta particles, recognized for their moderate penetration capabilities, have played a crucial role in addressing cellular malignancies, whereas gamma rays, which penetrate deeper into tissues, are frequently used for both imaging and therapeutic interventions. Nonetheless, despite their effectiveness, these radiation types are accompanied by certain drawbacks, including potential damage to adjacent healthy tissues and difficulties in achieving precise localized effects.

The introduction of alpha emitters has transformed the field of radiopharmaceuticals. These particles, distinguished by their high linear energy transfer (LET) and very limited penetration depths, provide exceptional accuracy in eliminating cancer cells while preserving surrounding healthy tissues. This characteristic renders alpha emitters particularly advantageous for targeting micrometastatic diseases and isolated malignant cells, offering a significant improvement over conventional beta and gamma therapies.

A significant achievement in the realm of targeted alpha therapy (TAT) is the approval of Xofigo (radium-223 dichloride). This alpha-emitting radiopharmaceutical has been approved for the treatment of patients with castration-resistant prostate cancer (CRPC) who exhibit symptomatic bone metastases without known visceral metastases. Its approval, based on the pivotal Phase 3 ALSYMPCA trial, demonstrated considerable survival advantages and pain alleviation for patients, establishing a new benchmark for the management of advanced-stage prostate cancer. Presently, Xofigo holds approval in over 50 countries, underscoring its global clinical and commercial success.

While Xofigo currently stands as the sole approved alpha emitting therapy, the field of targeted alpha therapy is experiencing rapid growth, particularly for solid tumors. Researchers are diligently exploring various alpha emitters to improve treatment effectiveness and expand therapeutic applications. Among these, Lead-212 has emerged as a notably promising option, demonstrating potential in numerous preclinical and clinical investigations. Additionally, researchers are examining uses beyond oncology, highlighted by a recent study from the University of Utah that assessed the efficacy of targeted alpha therapies in treating neurodegenerative diseases such as Alzheimer's. This illustrates the adaptability and extensive potential of alpha emitters in tackling a wide range of complex medical issues.

The landscape of clinical trials for TAT is both dynamic and competitive. Companies such as RayzeBio are at the forefront, with their candidate RYZ101 progressing to Phase 3 trials for patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. These tumors, which have advanced following previous Lutetium-177-based treatments, represent a significant unmet medical need. The advancement of RYZ101 highlights the increasing emphasis on alpha emitters as viable alternatives to current radiopharmaceuticals. Furthermore, the market has seen a surge of innovative preclinical candidates. In January 2024, Cellectar Biosciences reported promising preclinical results for CLR 121225, an alpha-emitting phospholipid radiotherapeutic conjugate aimed at pancreatic cancer. This development signifies a continued dedication to innovation and the potential for broadening TAT applications into previously unexplored areas.

Interest in TAT is not limited to established companies; new entrants are transforming the competitive environment by introducing novel mechanisms and expanding the array of alpha-emitting therapies. This surge of innovation is fostering partnerships, investments, and collaborative research initiatives, thereby generating momentum for additional clinical and commercial advancements. As the market progresses, the significance of alpha emitters in precision medicine is expected to increase, providing optimism for more effective and less invasive treatment options for a wide range of diseases. With the potential of targeted alpha therapy, the future of radiopharmaceuticals appears well-positioned to tackle some of the most urgent challenges in contemporary medicine.

Table of Contents

1. Introduction To Targeted Alpha Therapy

• 1.1 Overview
• 1.2 Alpha Radiation vs. Beta & Gamma Radiation In Cancer Therapy

2. Targeted Alpha Therapy - Structure & Mechanism Of Action

• 2.1 Structure
• 2.2 Mechanism Of Action

3. Targeted Alpha Therapy Applications By Cancer

• 3.1 Hematological Malignancies
• 3.2 Solid Tumors

4. Global Targeted Alpha Therapy Market Insight

• 4.1 Current Market Scenario
• 4.2 Future Growth Avenues

5. Targeted Alpha Therapy Market Insight By Region

• 5.1 US
• 5.2 Europe
• 5.3 China
• 5.4 Japan
• 5.5 Australia

6. Targeted Alpha Therapy Clinical Trials Insight By Company, Country, Indication & Phase

• 6.1 Research
• 6.2 Preclinical
• 6.3 Phase I
• 6.4 Phase I/II
• 6.5 Phase II
• 6.6 Phase II/III
• 6.7 Phase III

7. Marketed Targeted Alpha Therapy Clinical Insight By Company, Country & Indication

8. Xofigo - 1st Approved Targeted Alpha Therapy

• 8.1 Overview & Patent Insight
• 8.2 Pricing & Dosing

9. Targeted Alpha Therapy - Proprietary Technology Platform By Company

10. Global Targeted Alpha Therapy Market Dynamics

• 10.1 Drivers & Opportunities
• 10.2 Challenges & Restraints

11. Competitive Landscape

• 11.1 Actinium Pharma
• 11.2 AdvanCell
• 11.3 Bayer
• 11.4 Fusion Pharma
• 11.5 Johnson & Johnson
• 11.6 Modulation Therapeutics
• 11.7 Orano Med
• 11.8 Perspective Therapeutics
• 11.9 RayzeBio
• 11.10 Telix Pharmaceuticals

List of Figures

• Figure 2-1: Targeted Alpha Therapy - Structure
• Figure 2-2: Targeted Alpha Therapy - Mechanism Of Action
• Figure 3-1: LIN-AC225-AML02 Phase 1/2 (NCT03867682) Study - Initiation & Completion Year
• Figure 3-2: AcTRESS Phase 1 (NCT06411301) Study - Initiation & Completion Year
• Figure 3-3: RG1121028 Phase 1 (NCT04579523) Study - Initiation & Completion Year
• Figure 3-4: 225Ac-DOTA-daratumumab Phase 1 (NCT05363111) Study - Initiation & Completion Year
• Figure 3-5: PAnTHA Phase 1 (NCT06217822) Study - Initiation & Completion Year
• Figure 3-6: PSMA-617-100 Phase 1 (NCT04597411) Study - Initiation & Completion Year
• Figure 3-7: BAY3546828 Phase 1 (NCT06052306) Study - Initiation & Completion Year
• Figure 3-8: VMT-a-NET-T101 Phase 1/2a (NCT05636618) Study - Initiation & Completion Year
• Figure 3-9: FPI-2059-101 Phase 1 (NCT05605522) Study - Initiation & Completion Year
• Figure 4-1: Factors Influencing Future Market of Targeted Alpha Therapies
• Figure 4-2: Global - Targeted Alpha Therapy Market Opportunity (US$ Million), 2025 & 2028
• Figure 9-1: Fusion Pharma - Fast-Clear(TM) Linker Technology
• Figure 9-2: AdvanCell - Proprietary 212Pb Production Technology
• Figure 9-3: Cellectar Biosciences - Phospholipid Ether (PLE) Platform Technology
• Figure 9-4: Perspective Therapeutics - Proprietary Technology & Pb-212 Isotope

Generator VMT-a-NET

• Figure 10-1: Global Targeted Alpha Therapy Market - Drivers & Opportunities
• Figure 10-2: Global Targeted Alpha Therapy Market - Challenges & Restraints

List of Tables

Table 1 1: Alpha Radiation vs. Beta & Gamma Radiation In Cancer Therapy

• Table 4-1: Efforts to Increase Radioisotope Production Capacity
• Table 4-2: Recent Collaborations for Targeted Alpha Therapy Development
• Table 6-1: Targeted Alpha Therapies In Research Stage, 2024
• Table 6-2: Targeted Alpha Therapies In Preclinical Stage, 2024
• Table 6-3: Targeted Alpha Therapies In Phase I, 2024
• Table 6-4: Targeted Alpha Therapies In Phase I/II, 2024
• Table 6-5: Targeted Alpha Therapies In Phase II, 2024
• Table 6-6: Targeted Alpha Therapies In Phase II/III, 2024
• Table 6-7: Targeted Alpha Therapies In Phase III, 2024
• Table 7-1: Marketed Targeted Alpha Therapies, 2024
• Table 8-1: Xofigo - Decay Correction Factor